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Epidemiology > Exam 2 : Lecture Interventional > Flashcards

Exam 2 : Lecture Interventional Flashcards

1
Q

Other terms for interventional

A 
Clinical trial
Clinical study
Experimental study
Human study
Investigational study
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2
Q

Interventional studies are MORE rigorous in ability to show cause-and-effect . T or F

A

True

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3
Q

Interventional studies CANT demonstrate causation. T or F?

A

False. They CAN

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4
Q

Prior to human investigation this level used animal research “bench”

A

Pre-clinical

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5
Q

In this phase we:

  1. Assess drug target actions and pharmacokinetics in non therapeutic/non-diagnostic doses
  2. Healthy volunteers (diseased in oncology)
  3. Very small numbers
  4. Very short duration
A

Phase 0

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6
Q

In this phase we:
1. Assess safety/tolerance and pharmacokinetics of one or more dosages
2. Healthy or disease volunteers (depends on disease)
3. Small numbers (20-80)
Short duration (just a few weeks)

A

Phase 1

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7
Q

In this phase we:

  1. Asses effectiveness
  2. Disease volunteers
  3. Larger number (100-300)
  4. Short to medium duration (few weeks to a few months)
A

Phase 2

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8
Q

In this phase we:

  1. Asses effectiveness
  2. Diseased volunteers
    - superiority
    - noninferiority
    - equivalency
  3. Larger number (300-500)
  4. Longer duration (few months to a year +)
A

Phase 3

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9
Q

Phase three can be run multiple times, T or F?

A

True. It can be run multiple times

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10
Q

If the drug isn’t yet on the market, what phase is it in?

A

Phase 3

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11
Q

Every time phase three is tested, it must be successful to move on to stage 4. T or F?

A

False. It just needs to majoritively test positive

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12
Q

In this phase we:

  1. Assess long-term safety, effectiveness, optimal use
  2. Diseased voulnteers
  3. Population (100,000)
  4. Longer duration (many years to decades)
A

Phase 4

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13
Q

FDA approval phase

A

Phase 4

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14
Q

What are some advantages of interventional trials

A
  1. Cause precedes effect (can demonstrate causation)

2. Only design-family used by FDA for “approval” process

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15
Q

Disadvantages of interventional trials?

A

Cost
Complexity
Ethical considerations
Generalizability

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16
Q

This interventional study divides subjects exclusively int o2 or more groups. Asks a single question. What study design is it?

A

Simple

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17
Q

This interventional study design divides subjecting into 2 or more groups and then further sub divides each of the groups into 2 more additional groups. Tests multiple hypothesis. What design is this?

A

Factorial

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18
Q

What are some benifits and risks to using factorial interventional studies?

A 
Improves efficiency for answering clinical questions
Increases study population sample size
Increases complexity
Increases risk of drop outs
May restrict generalizability of results
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19
Q

Are simple and factorial study designs also parallel?

A

Yes

NO SWITCHING

20
Q

In this interventional study design groups serve as their own control by crossing over from one intervention to another during the study. What design is this?

A

Cross-over (self control)

21
Q

Which interventional design has a wash out phase?

A

Cross-over

22
Q

Disadvantages of cross-over design?

A
  1. Only suitable for long-term conditions which are not curable or which treatment provides short-term relief
  2. Duration of study for each subject is longer
  3. Carry-over effects during cross-over
  4. Treatment by period interaction
  5. Smaller number requirement only applicable if within subjects variation less than between subjects variation
  6. Complexity in data analysis
23
Q

Patient oriented endpoint (POEM’s)

A

Death
Stroke
Hospitalization
Preventing need for dialysis

24
Q

Disease oriented endpoints (DOE’s)

A

Blood pressure
Cholesterol
Change in SCr

25
Q 
Sample selection:
Patients dont have an equal probability of being selected. 
Ex: all of the 8 am epi class is selected for group 1 and all of micro is group 2
A

Non-random

26
Q

What table is customarily use to show group characteristics?

A

Table 1

27
Q

Equality of groups is guaranteed in randomization. T or F?

A

False

28
Q

Examples of forms of randomization

A

Simple
Blocked
Stratified

29
Q

Simple randomization

A

Equal probability for allocation within one of the study groups

30
Q

Blocked randomization

A

Every 20 you peak at the groups to make sure they are equal

Ensures balance within each intervention group

31
Q

Stratified randomization

A

Ensures balance with known confounding variables

Ex: equal number of ages in both groups, check as you go.

32
Q

Types of masking

A

Single

Double

33
Q

Single mask

A

Study subjects not informed which intervention group they are in, yet investigators are permitted to know
Fine for: objective (blood pressure monitoring extc..)

34
Q

Double blind

A

Neither investigator nor study subjects are informed which intervention group subjects are in
-post surveys are used to assess credibility (adequacy) of double blind

35
Q

Open label

A

Study subjects and researchers know what intervention is being received

36
Q

What can be used to assess adequacy of blinding

A

Post hoc survey’s

37
Q

Plaebebo

A

Inert treatments made to look identical in all aspects to the active treatment

38
Q

Double dummy

A

More than 1 placebo

39
Q

Hawthorne-effect

A

Study subjects change their behavior solely due to awareness of being studied

40
Q

Post hoc sub group analysis is always accepted as appropriate. T or F?

A

False. It’s only appropriate when its been planned for.

41
Q

How doe we manage drop-outs/lost to follow ups?

A

Intention to treat

42
Q

Intentions to treat

A

Use last known assessment

Convert all subsequent yet missed assessments for a subject to a null effect

43
Q

Per-protocol or efficacy analysis?

A

Ignore drop outs

Include only the compliant or completing subjects

44
Q

Assess adherence (compliance) how

A

Drug levels
Pill count
Bottle counter tops

45
Q

Methods of improving adherence?

A

Frequent follow up visits
Treatment alarms
Medication blister packs or dosage containers

Epidemiology (9 decks)

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